A number of diseases may be effectively treated if a sustained delivery of a medicinal drug (also referred to herein as a therapeutic medium, therapeutic agent, or medicinal agent) is provided in accordance with a protocol (medicine dosage and the schedule of administering the medicine) recommended by a treating physician. Unfortunately, patients' non-compliance with taking their medications usually undermines the efficiency and outcome of medical treatment. In other words, prescribed medications will hardly work in patients who either do not take them or fail to follow a recommended regimen (protocol or schedule) of medications intake.
Some conventional implant systems utilize a concept of delivering a deflated balloon into a cavity of a patient's body and subsequent inflating of the balloon to anchor the balloon in place. Such common procedures are found in angioplasty, and other procedures. However, these systems do not use the anchored balloon filled with a medicinal agent for subsequent expelling into the body of a patient. These systems do not use a bioresorbable composition for balloon implant fabrication, since such requires the inflated balloon to remain in place intact, especially in case of angioplasty or the like.
Most drug delivery implant systems use Non-resorbable Drug Delivery Systems (DDSs), such as, for example, inflated balloons (generally used for unblocking veins), which are removed at the end of the procedure to provide a cleared pathway for blood flow.
The non-resorbable sub-cutaneous drug delivery system implants are produced by, for example, Debiotech, which fabricates a silicon nano-porous membrane system Debiostar, which delivers somatostatin.
Another drug delivery implant system, such as a DUROS implant platform, is designed with the implant for releasing leuproliode medicine for treating prostate cancer, as well as Exenatide (GLP-1 agonist) for treating type-2 diabetes, or pain medications. The DUROS uses a titanium implant DDS that is osmotically driven and provides “zero order” drug delivery.
Both Debiostar and DUROS must have their implants surgically removed after the drug “pay-load” has been delivered.
The Robert Langer Laboratory at MIT has developed a resorbable multi-reservoir (36 reservoirs) DDS fabricated from poly (L-lactide) and PLGA membranes of different molecular masses, each for covering a respective one of 36 reservoirs that releases pulses of different drugs at intervals after the implantation procedure.
This is, however, a somewhat complex and expensive implant system requiring several types of bioresorbable polymers (of different molecular masses) mixed (or impregnated) with respective medicinal agents to be fabricated in a single implant.
In addition, this system is fabricated with the medicinal agent(s) pre-loaded in the implant prior to the implantation in the body of a patient, which requires a sufficient receiving volume to retain the medicinal agents. Microchips as large as ˜1.2 cm in diameter are fabricated which are pre-loaded with medicinal agents. The dimensions of the MIT's implant exceeds a desired range appropriate for a sub-cutaneous implantation procedure.
Numerous eye disorders may permanently damage vision in an affected eye and possibly lead to blindness if untreated. Such vision threatening disorders include, for example, ocular neovascularization, ocular inflammation, retinal degeneration, and retinal detachment.
Various diseases of the eye have been conventionally treated by injection directly through the sclera of a medicinal drug composition. This approach limits effective delivery of therapeutic medium to the retina/choroid when the therapeutic medium is injected directly into the vitreous, and fails to provide for a sustained therapy for the target tissue.
Additionally, such prior art procedures, do not permit the maintenance of the medicinal drug in a relatively stable position within the vitreous and may produce side effects associated with the injection of drugs directly. Prior art procedures either allow the device to be free floating in the vitreous cavity or the device is anchored to the eye wall with an external element that protrudes outside of the sclera. The protruded element poses a risk for erosion/extrusion of the device and infection of the patient's eye.
Thus, there is a longlasting need for a device or system that can overcome this non-compliance issue by providing an uninterrupted and steady-state release of a drug or a medicinal agent in a patient's body over an extended period of time as prescribed by physician. Such a device (or system) should be able to provide sustained delivery of a medicinal drug at a predetermined dosage level to a specific organ (or part of the body) or provide systemic delivery of the drug or medicinal agent throughout the entire body of the patient. Ideally, such a device (or system) is to be inert to tissues and fluids of the body, non-inflammatory, and bioresorbable, that is, should dissolve without a trace after the medicinal agent (or drug) has been completely released into the patient's body or a specific organ.
A number of diseases require the attachment-and-reattachment of a patient's tissue to other tissues of the patient, such as, for example, in treatment of retina detachment. In traditionally performed ophthalmic procedures, systems for treating retina detachment provide for a band to be positioned surgically around the sclera of the eye to force or displace the sclera into contact with the retina, and a scleral buckle (or band) is permanently sewn to the globe.
However, such traditional ophthalmic procedures are location sensitive and are not capable of providing a continuous interface of the retina with the sclera. In addition, this approach is prone to cause several disadvantageous outcomes including induced myopia (nearsightedness), erosion/extrusion of the band potentially leading to infection, double vision, and chronic eye pain.
In an effort to circumvent these problems, a temporary and removable scleral buckle has been introduced in the field of ophthalmic surgeries. These devices are implanted for a predetermined time duration, and subsequently are removed in a separate surgical procedure. One of these devices is what is commonly known as the Lincoff buckle.
Other prior devices (such as that described, for example, in U.S. Pat. No. 5,286,261) are designed for correcting retinal detachments by heat shrinking of a scleral band for scleral indentation over a tear region.
More recently Tornambe developed a solid version of a temporary scleral buckle which is removed in a separate surgical procedure three weeks after attachment of the scleral buckle, as referenced in “Retinal Physician,” Jul. 1, 2014, London, N J S, Tornambe P E. Clearly, the need for an additional surgical procedure to remove the implant post-operationally is a disadvantage of such an approach.
Therefore, there is a need for a temporary scleral buckle that indents the eye wall/sclera long enough to reattach the retina, and which subsequently can completely reabsorb, thus avoiding the need for additional surgery.
Some prior art systems (such as that described, for example, in U.S. Patent Application Publication No. 2010/0114074) are directed to delivery systems for release of an active agent to body cavities for a predetermined administration time period. However such systems are extraneous to a concept of insertion of an active (therapeutical) agent into a bioresorbable balloon-like member implanted in the body for permitting the active agent to be dispersed in the patient's body (or an organ) from the balloon-like member over a period of time. In addition, the conventional delivery systems do not address absorption of the implanted member into the patient's body.
In general, it is a long-lasting need in the surgical art for a sub-cutaneous drug delivery implant system which would be fully bio-resorbable in the patient's body after the medicinal agent has been delivered, and which would be small enough for ease of implantation and comfort of the patient, and which would be fabricated through a simple and inexpensive manufacturing process.